A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder

NCT07775300
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
1,000
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Lead sponsor
Eli Lilly and Company
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Start date
2026-08-14
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Number of sites
170
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Summary
This study evaluates the safety and efficacy of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC in delaying the return of major depressive symptoms. The trial is divided into three periods as follows: a screening period that will last approximately 1 month, a treatment period that will last a minimum of 12 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if depression symptoms worsen or if withdrawal from the study occurs for any reason.
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Acronym
RENEW-MDD- 2
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Short title
A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder
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Official title
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Delaying Time to Relapse Compared With Placebo in Adult Participants With Major Depressive Disorder (RENEW-MDD- 2)
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2029-02-01
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First posted
2026-08-20
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Registry last updated
2026-10-07
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Primary completion date
2028-12-01
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Start date
2026-08-14
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Participants
1,000
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Participant count basis
Estimated
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Planned participants
1,000
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Protocol amendments
0
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Number of sites
170
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07775300
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ClinicalTrials.gov ID
NCT07775300
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Time to Relapse Defined as the Number of Days from Randomization to Date on Which the Participant Meets Any Relapse Criterion of Major Depressive Disorder (MDD)

    Timeframe: From Randomization in Double-Blind Adjunctive Treatment to First Relapse For at Least 12 Months

  1. Mean Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index (BMI) ≥ 25.0 kg/m^2

    Timeframe: Baseline, up to at least 6 months

  2. Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score

    Timeframe: Baseline, up to at least 6 months

  3. Change from Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score

    Timeframe: Baseline, up to at least 6 months

  4. Change from Baseline in Patient-Reported Outcomes Measurement Information Systems (PROMIS) Short Form

    Timeframe: Baseline, up to at least 6 months

  5. Change from Baseline in Patient Global Impression of Severity (PGI-S)

    Timeframe: Baseline, up to at least 6 months

  6. Change from Baseline in Generalized Anxiety Disorder (GAD) - 7 Total Score

    Timeframe: Baseline, up to at least 6 months

  7. Change from Baseline in Patient Rated Symptom and Disease Severity

    Timeframe: Baseline, up to at least 6 months

  8. Change from Baseline in Recovering Quality of Life - 20 Items (ReQoL-20) Total Score

    Timeframe: Baseline, up to at least 6 months

  9. Mean Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index (BMI) ≥25 kg/m² and on an Atypical Antipsychotic

    Timeframe: Baseline, up to at least 6 months

  10. Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide

    Timeframe: Baseline, up to at least 6 months

  11. Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADA

    Timeframe: Baseline up to at least 6 months

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  • Meet the diagnostic criteria for major depressive disorder

  • Are on stable standard of care medication for major depressive disorder

  • Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as

    • self-inject study intervention
    • store and use the provided blinded study intervention, as directed
    • maintain electronic and paper study diaries, as applicable, and
    • complete the required questionnaires

  • Have a lifetime history or current diagnosis of the following:

    • schizophrenia spectrum or other psychotic disorder
    • bipolar disorder
    • borderline personality disorder, or
    • any eating disorder

  • Have type 1 diabetes mellitus, or a history of:

    • ketoacidosis, or
    • hyperosmolar state or coma.

  • Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening

  • Are actively suicidal or deemed a significant risk for suicide

  • Have participated in a clinical study and received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening

Sources for eligibility
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  • University of Alabama at Birmingham - School of MedicineBirmingham, United StatesRecruiting
  • NoesisPharma, LLCPhoenix, United StatesRecruiting
  • Irvine Clinical ResearchIrvine, United StatesRecruiting
  • Healthy Brain ClinicLong Beach, United StatesNot yet recruiting
  • Oakland ClinicalOakland, United StatesRecruiting
  • Concierge Clinical TrialsValley Village, United StatesRecruiting
  • JEM Research InstituteAtlantis, United StatesRecruiting
  • Bradenton Research Center, Inc.Bradenton, United StatesRecruiting
  • Key Clinical ResearchBradenton, United StatesRecruiting
  • NextPhase Research Florida - HollywoodHollywood, United StatesRecruiting
  • Miami Jewish healthMiami, United StatesNot yet recruiting
  • Quantix Research - Miami - Southwest 72nd StreetMiami, United StatesRecruiting
  • Diverse Clinical ResearchMiami, United StatesRecruiting
  • CLA ResearchNaples, United StatesRecruiting
  • Health Synergy Clinical ResearchWest Palm Beach, United StatesRecruiting
  • CenExel iResearch, LLCDecatur, United StatesNot yet recruiting
  • AGILE Clinical Research Trials, LLCSandy Springs, United StatesRecruiting
  • Charter Research - ChicagoChicago, United StatesRecruiting
  • Pharmasite Research, Inc.Baltimore, United StatesRecruiting
  • Adams Clinical BostonBoston, United StatesRecruiting
  • Adams Clinical WatertownWatertown, United StatesRecruiting
  • Arcturus Healthcare , PLC, Troy Internal Medicine Research DivisionTroy, United StatesRecruiting
  • Be Well Clinical Studies - OmahaOmaha, United StatesRecruiting
  • Adams Clinical BronxThe Bronx, United StatesRecruiting
  • Adams Clinical PhiladelphiaPhiladelphia, United StatesRecruiting

And 145 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-522310-24-00
  • J2S-MC-GZMI
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (3)